IV Phenylephrine bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalled 9,432 IV bags containing phenylephrine due to lack of assurance of sterility and insufficient validation data for decontamination cycles. The product was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II sterile injectable medication with potential microbial contamination risk. No reported illnesses or injuries. Classified as High per the rubric's criterion for risk-of-harm products without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 9,432 bags of phenylephrine 40 mg/250 ml IV solution (NDC: 72196-6092-1) distributed nationwide in the United States.
The recall was initiated due to lack of assurance of sterility. The manufacturer was unable to provide sufficient validation data for the decontamination cycles used in production of these IV bags.
This product may have been distributed to hospitals and healthcare facilities across the United States. Healthcare providers who received this product should stop using it immediately.
For instructions on return or disposal, contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043.
The recalled product
- Product
- PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solutions
- Hazard
- sterility-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot: 36-240803
- Exp. 7/17/2023
- 36-241149
- Exp. 7/19/2023
- 36-241912
- Exp. 7/23/2023
- 36-243527
- 36-243529
- Exp. 7/30/2023
- 36-244889
- 36-244890
- 36-244891
- Exp. 8/1/2023
- 36-246709
- 36-246710
- 36-246711
- 36-246712
- Exp. 8/6/2023
- 36-247014
- Exp. 8/7/2023
Distribution
Distributed nationwide across the United States.
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